RestoreX® with CCH (Xiaflex®) Trial
Mayo Clinic researchers completed a clinical trial using RestoreX with Xiaflex® (2) to determine the efficacy of the two treatments together. A registry was maintained of all men undergoing CCH injections for PD from March 2014 through Jan 2019 at the Mayo Clinic. Assessments were performed at baseline, during each series, and after completing treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into Group 1 (CCH alone), Group 2 (CCH + any PTT other than RestoreX), or Group 3 (CCH + RestoreX). The trial is described in the schematic below.
After 24 weeks the patients in each group were assessed for reduction in curvature and improvements in lost length. In the CCH (Xiaflex) alone group, the mean reduction in curvature was approximately 20° or about 31%. The results were the same when used with other PTT devices. With RestoreX, however, mean change in curvature improved by about 70% from 20° to 34°. On average men who used RestoreX during the cycles of Xiaflex experienced nearly a 50% reduction in curvature.
Regarding length improvements, not surprisingly, CCH (Xiaflex) alone did not result in any improvement in lost length. Xiaflex with first generation PTT devices also had not impact on length. When patients used RestoreX along with the injection treatment, they experienced a nearly 2cm gain in length or about 17%. As shown, all outcomes were statistically significant.
In conclusion, “the combination of RestoreX an CCH (Xiaflex) is associated with significantly greater curvature and length improvements compared to CCH alone or CCH with other PTT devices.”(2)
- Xiaflex Is a registered trademark of Endopharmaceuticals, Inc.
- Combination of Collagenase Clostridium Histolyticum and Penile Traction with REstoreX Results in Greater Improvements in Curvature and Length in Men with Peyronie’s Disease. Andrews, Aloom, Sharma, Toussi, Kohler and Trost. Presentation at the Southeastern Section of the AUA, March 2019